Incidence of Infection Reported by COVID-19 in Attendees of a Commercial Music Concert

Observational Study of the Incidence of Infection Reported by SARS CoV-2 in Attendees of a Commercial Music Concert at the Palau Sant Jordi (Barcelona)

From the beginning of the pandemic caused by SARS-CoV-2, most events with massive participants have been canceled due to being considered high-risk events for the SARS-CoV-2 transmission. It has been detected that asymptomatic people infected by SARS-CoV-2, are playing an important role in the contagious in these kinds of events. The economic losses arising from the closure of these activities, mainly those related to culture and musical performances are around 2.5 billion euros a Catalonia, and a considerable loss of jobs in this sector.

Developing strategies of cribrate of infected people by SARS-CoV-2 asymptomatic or not diagnosticated and with a potential transmission of the virus is the key to perform cultural, sport, etc. massive events with all the security. The objective is to exclude infected people with a a high potential of transmission.

It is needed to use versatile tests for this objective, so the test must have a high sensibility to detect infected people, the test has to be easy to manipulate without requiring a high technology of the laboratory hospitals, neither prolongated to obtain a result and that has a low cost. The rapid SARS-CoV-2 antigen screening tests are best suited for this purpose.

On 27th March, a musical concert will be performed at Palau St Jordi (Barcelona) with 5000 attendees and with all the SARS-COV-2 safety measures by the "Secretary General of Health of the Generalitat de Catalunya" a (mandatory wearing a mask during the event, restricted outdoor areas of bar and smoking enhanced ventilation of the whole indoor area and avoiding queues.). This study wants to assess the incidence of SARS-CoV-2 infection reported to the health system among the attendees of this commercial concert during the 14 days following the event, also it will be evaluated the clinical evolution of the possible infections during the concert.

Study Overview

• Status: Completed
• Conditions: Covid-19 (SARS-CoV-2)

Detailed Description

From the beginning of the pandemic caused by SARS-CoV-2, most events with massive participants have been canceled due to being considered high-risk events for the SARS-CoV-2 transmission. It has been detected that asymptomatic people infected by SARS-CoV-2, are playing an important role in the contagious in these kinds of events. The economic losses arising from the closure of these activities, mainly those related to culture and musical performances are around 2.5 billion euros a Catalonia, and a considerable loss of jobs in this sector.

Developing strategies of cribrate of infected people by SARS-CoV-2 asymptomatic or not diagnosticated and with a potential transmission of the virus is the key to perform cultural, sport, etc. massive events with all the security. The objective is to exclude infected people with a a high potential of transmission.

It is needed to use versatile tests for this objective, so the test must have a high sensibility to detect infected people, the test has to be easy to manipulate without requiring a high technology of the laboratory hospitals, neither prolongated to obtain a result and that has a low cost. The rapid SARS-CoV-2 antigen screening tests are best suited for this purpose. These tests have shown a sensitivity close to 99% to detect infectious people who have a high viral load of SARS-CoV-2. No viral isolation has been demonstrated in any culture of samples of patients infected with SARS-CoV-2 with a Ct threshold (cycle threshold) in the test RT-PCR greater than 30, which is considered to delimit the transmitting potential of the infected

On 27th March, a musical concert will be performed at Palau St Jordi (Barcelona) with 5000 attendees and with all the SARS-COV-2 safety measures by the Secretaria General de Salut de la Generalitat de Catalunya (mandatory wearing a mask during the event, restricted outdoor areas of bar and smoking enhanced ventilation of the whole indoor area and avoiding queues.). This study wants to assess the incidence of SARS-CoV-2 infection reported to the health system among the attendees of this commercial concert during the 14 days following the event, also it will be evaluated the clinical evolution of the possible infections during the concert.

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Germans Trias I Pujol Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the commercial concert attendees, that are major of age (>18 years old) and who have signed the informed consent to access their Medical records 14 days after the commercial concert.

Description

Inclusion Criteria:

• Adults (> 18 years and under 65) attending the commercial music event scheduled at the Palau Sant Jordi
• Sign informed consent, including an authorization for the collection of data from the electronic health system of the Catalan System of Health on the notification of COVID-19 infection during the 14 days following the event or authorization to be contacted by telephone by the medical team, if necessary, for complete information on SARS-CoV-2 infection.

Exclusion Criteria:

• Minors (<18 years)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of people with SARS-CoV-2	Incidence rate of assistants with reported SARS-COV-2 14 dys after the event	From day 1 to day 14 after the event
Incidence rate of consultations in primary care centers	Incidence rate of consultations in primary care centers about symptoms compatible with COVID-19 during the 14 days after the event	From day 1 to day 14 after the event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of Hospital emergencies	Incidence rate of hospital emergencies about symptoms compatible with COVID-19 during the 14 days after the event	From day 1 to day 14 after the event
Incidence rate of hospital admissions	Incidence rate of hospital admissions about symptoms compatible with COVID-19 during the 14 days after the event	From day 1 to day 14 after the event
Incidence rate of Intensive care units admissions	Incidence rate of intensive care units in the concert participants with COVID-19 during the 14 days after the event	From day 1 to day 14 after the event
Incidence rate of mortality	Incidence rate of COVID-19 mortality in the concert participants during the 14 days after the event	From day 1 to day 14 after the event

Collaborators and Investigators

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: Festivals per la Cultura Segura AIE

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2021
• Primary Completion (Actual): March 27, 2021
• Study Completion (Actual): April 10, 2021

Study Registration Dates

• First Submitted: March 27, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; Superspreading event; Concert
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: StJordi-CoV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No